Collection of Samples From Patients With MDS
Collection of Bone Marrow, Peripheral Blood (PB), Epithelial Tissue, and Saliva Samples From Patients With Myelodysplastic Syndromes (MDS) to Identify MDS-Specific Antigens (MSA) for Use in Cellular Immunotherapy.
1 other identifier
observational
24
1 country
2
Brief Summary
The purpose of this study is to collect information and bone marrow, blood, saliva, cheek cells and skin to be used in the laboratory to assist the sponsor in identifying a new way of treating MDS.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Apr 2017
Longer than P75 for all trials
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 1, 2017
CompletedFirst Posted
Study publicly available on registry
March 7, 2017
CompletedStudy Start
First participant enrolled
April 6, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 5, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
March 5, 2021
CompletedMarch 26, 2019
March 1, 2019
3.7 years
March 1, 2017
March 25, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
Genomics of patients with MDS
To sequence the exome and transcriptome obtained from MDS hematopoietic cells and the exome from non-hematopoietic cells (e.g. fibroblasts).
2 years
Secondary Outcomes (5)
Identification of patients' MDS-specific variant
2 years
Immunogenic mutant neoantigen peptide selection
2 years
Peptide Immunogenicity confirmation and donor T cell stimulation
2 years
Peptide immunogenicity confirmation and donor T cell stimulation
2 years
Data analysis and interpretation
2 years
Eligibility Criteria
Approximately 24 Subjects (patients and donors) will be recruited over a 3-year period. Both male and female subjects will be included and there will be no restrictions based on race or ethnicity.
You may qualify if:
- Diagnosis or suspected diagnosis of MDS or CCUS
- Age 18 or older
You may not qualify if:
- Currently receiving or within 3 months has received hypomethylating agent(s), lenalidomide, cytotoxic agents, or within the previous 4 weeks corticosteroids \> 5 mg prednisone daily or any other immunosuppressants
- Previous allogenic transplant
- Inability to provide consent
- Prisoners
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- PersImmune, Inclead
- University of California, San Diegocollaborator
Study Sites (2)
University of California, Irvine
Irvine, California, 92868, United States
University of California San Diego
La Jolla, California, 92093, United States
Biospecimen
We intend to obtain cells from bone marrow, peripheral blood, epithelial tissue, and saliva from patients who are likely to be candidates for MDS treatment in the near future.
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Rafael Bejar, MD
UCSD
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 1, 2017
First Posted
March 7, 2017
Study Start
April 6, 2017
Primary Completion
December 5, 2020
Study Completion
March 5, 2021
Last Updated
March 26, 2019
Record last verified: 2019-03